PPD is a leading global contractresearch organization. At PPD we are passionate, deliberate, and drivenby our purpose - to improve health!
PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.
As a Senior Scientist, you are committed to excellence and high quality results in your complexlaboratory analysis of key pharmaceutical products. Beyond the bench, you workas a project leader with a strong sense of urgency aligned to our customers,and you are committed to delivering results.
Responsibilities for this position:
We are looking for a highly motivated person who supports analytical development and routine testing of NBEs. The candidate will identify, investigate and implement novel experimental approaches to answer scientific questions to develop and optimize NBE drug product formulations. Working closely with formulation and process development scientists, the candidate will develop productive collaborations and communications with scientific teams.
- Analytical characterization and assessment of clinical trial supplies (e.g. GMP compliant stability and release testing)
- Execute and design experiments for method validation studies.
- Documents experimental data appropriately in laboratory documentation system and technical memos; contributes to writing technical reports.
- Maintains laboratory equipment and optimize laboratory operations for efficient use of time and resources.
- Lead troubleshooting of equipment and experimental problems.
- Brainstorm ideas for continuous improvement activities and leads initiative.
- Responsible for compliance with all applicable Client policies and procedures.
- Understand and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.
Independently performs method validations, method transfers and analytical testing of pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems. Understands and conforms to methods and protocols applicable to assigned tasks. Designs and executes experiments with minimal supervision
Prepares study protocols, project status reports, final study reports and other project-related technical documents
Communicates data and technical issues to the client and responds to client needs and questions
Mentors, trains and coordinates laboratory activities of other team members and assists in troubleshooting instrument and analytical problems
Assists with quality systems and new equipment
Assists in designing method validation or method transfer protocols and establish project timelines
Reviews, interprets, and analyzes data for technical, quality, and compliance to protocols, methods, SOPs, client criteria, and GMP or GLP.
Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers
PPD offer continued career advancement as a Scientist, as well as management and specialized opportunities in other departments within PPD.
At PPD we hire the best, develop ourselves andeach other, and recognize the power of being one team. It's not just talk, ouraward-winning training programs speak for themselves.
To learn how PPD can advance your career, apply now!
What To Expect Next
We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.
- Bachelor's degree or equivalent and relevant formal academic/ vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 + years)
Knowledge, Skills andAbilities:
- Experience in analytical methodology, such as chromatography, KF, UV and compendial methods. Experience in bioanalytical techniques preferred (WCX, HIC, SEC, CGE, icIEF, particle imaging).
- At least two years of HPLC experience is required.
- Experienced in laboratory systems (LIMS, CDS, ELN) preferred.
- Experience in Microsoft Office (Excel, Power Point, and Word) required.
- Statistical knowledge and experience is preferred e.g. capability analysis, gauge R&R and design of experiments (DOE) methodologies
- Solid understanding and knowledge of general chemistry and separation science
- Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance
- Ability to utilize Microsoft Excel and Work to perform tasks
- Maintain a laboratory notebook and complete all documentation with clear and accurate language and according to the SOP
- Proficiency on technical operating systems
- Proven problem solving and troubleshooting abilities
- Effective oral and written communication skills
- Proven ability in technical writing skills
- Time management and project management skills
- Ability to work in a collaborative work environment with a team
- Proven problem solving and troubleshooting abilities
- Ability to train junior staff
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.Below is listed the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
- Able to work upright and stationary and/or standing for typical working hours
- Able to lift and move objects up to 25 pounds
- Able to work in non-traditional work environments
- Able to use and learn standard office equipment and technology with proficiency
- May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
- Regular and consistent attendance